Drug Master File for Collagenase

DMF Filed for Collagenase to Easily Facilitate FDA Approval

Drug Master File just filed for 

SERVA Collagenase NB 6 GMP Grade


Collagenase NB 6 GMP Grade is optimized for

 isolation of cells designated for transplantation into humans

 


Registering a New Drug Application? Applying for Export? 

NEW Drug Master File for Collagenase NB 6 GMP Grade

♢ Allows for a smoother and hassle-free registration process with the FDA
Faster registration
Less paperwork for applicants

According to the guidelines provided by the FDA, the Drug Master File (DMF) allows authorities to obtain necessary information to support

♢ Investigational New Drug Application (IND)
♢ New Drug Application (NDA)
♢ Abbreviated New Drug Application (ANDA)
♢ Another DMF or Export Application 
♢ Amendments/supplements to any of these applications.


SERVA GMP Collagenase with DMFs

 SERVA Enzymes currently available with DMF submission  

 ♢ 17458.03 Collagenase NB 6 GMP Grade

♢ 17452.01 Collagenase NB 1 GMP Grade

♢ 30303.01 Collagenase Neutral Protease GMP

SERVA Collagenases* are available in the United States through Crescent Chemical Company and worldwide through Serva. SERVA Collagenase NB 6 is produced by Nordmark, the world's largest and leading manufacturer of Collagenase. 

*For cell isolation only. Not intended for topical applications.